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Trial record 68 of 1271 for:    IFNA2

Clinical Trial of Low Dose Oral Interferon Alpha in Idiopathic Pulmonary Fibrosis

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ClinicalTrials.gov Identifier: NCT01442779
Recruitment Status : Completed
First Posted : September 29, 2011
Results First Posted : September 29, 2011
Last Update Posted : April 20, 2012
Sponsor:
Collaborator:
Amarillo Biosciences, Inc.
Information provided by (Responsible Party):
Texas Tech University Health Sciences Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Respiratory Tract Diseases
Lung Diseases
Lung Diseases, Interstitial
Pulmonary Fibrosis
Intervention Drug: Interferon alpha oral lozenge
Enrollment 18
Recruitment Details Medical clinic
Pre-assignment Details  
Arm/Group Title Interferon Alpha
Hide Arm/Group Description Treatment with low dose oral interferon alpha lozenges taken 3 times daily (approximately 6 hours apart). Lozenge is to be dissolved under tongue or by moving around in mouth.
Period Title: Overall Study
Started 18
Completed 11
Not Completed 7
Reason Not Completed
Withdrawal by Subject             3
Death             3
Non-compliance             1
Arm/Group Title Interferon Alpha
Hide Arm/Group Description Treatment with low dose oral interferon alpha lozenges taken 3 times daily (approximately 6 hours apart). Lozenge is to be dissolved under tongue or by moving around in mouth.
Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
<=18 years
0
   0.0%
Between 18 and 65 years
7
  38.9%
>=65 years
11
  61.1%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
67  (8.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
9
  50.0%
Male
9
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants
18
1.Primary Outcome
Title Minimal/no Progression (1 yr) by High Resolution Computed Tomography (HRCT) & Pulmonary Function
Hide Description Disease progression was determined by comparing results of the High Resolution Computed Tomography(HRCT) and pulmonary function at one year to the baseline HRCT & pulmonary function. The same radiologist did the comparsion for all subjects.
Time Frame 1 yr
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Interferon Alpha
Hide Arm/Group Description:
Treatment with low dose oral interferon alpha lozenges taken 3 times daily (approximately 6 hours apart). Lozenge is to be dissolved under tongue or by moving around in mouth.
Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: Participants
12
2.Primary Outcome
Title Minimal/no Change in Quality of Life
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed only on those subject who continue on medication for at least one year.
Arm/Group Title Interferon Alpha
Hide Arm/Group Description:
Treatment with low dose oral interferon alpha lozenges taken 3 times daily (approximately 6 hours apart). Lozenge is to be dissolved under tongue or by moving around in mouth.
Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: Participants
12
3.Secondary Outcome
Title Participants With Change in Cough
Hide Description changes in cough status after treatment for 1 month.
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
During the course of the study it was noted that subjects experienced a change in the cough that is sometimes associated with IPF. The 6 subjects still enrolled in the study were asked to complete a questionnare regarding the status of the cough.
Arm/Group Title Interferon Alpha
Hide Arm/Group Description:
Treatment with low dose oral interferon alpha lozenges taken 3 times daily (approximately 6 hours apart). Lozenge is to be dissolved under tongue or by moving around in mouth.
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: Participants
5
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Interferon Alpha
Hide Arm/Group Description Treatment with low dose oral interferon alpha lozenges taken 3 times daily (approximately 6 hours apart). Lozenge is to be dissolved under tongue or by moving around in mouth.
All-Cause Mortality
Interferon Alpha
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Interferon Alpha
Affected / at Risk (%) # Events
Total   4/18 (22.22%)    
Respiratory, thoracic and mediastinal disorders   
Death * [1]  4/18 (22.22%)  4
*
Indicates events were collected by non-systematic assessment
[1]
The deaths that occurred were complications of the disease (IPF), not related to the study drug
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Interferon Alpha
Affected / at Risk (%) # Events
Total   0/18 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Lorenz Lutherer, MD, PhD
Organization: Texas Tech University Health Sciences Center
Phone: 806-743-2532
Responsible Party: Texas Tech University Health Sciences Center
ClinicalTrials.gov Identifier: NCT01442779     History of Changes
Other Study ID Numbers: 00190
First Submitted: September 23, 2009
First Posted: September 29, 2011
Results First Submitted: September 23, 2009
Results First Posted: September 29, 2011
Last Update Posted: April 20, 2012